Senior RA Associate Consultant

This is a fully remote position, open to applicants in Mexico.

📋 Description

• Collaborate with the regulatory project team to review, update, and develop Technical Documents in compliance with EU MDR and relevant regulatory standards.

• Establish and sustain a thorough understanding of EU MDR and global medical device regulatory frameworks.

• Identify relevant regulatory requirements, harmonized standards, guidance documents, and submission expectations.

• Draft, create, and revise Technical Documents in collaboration with the Platform RA Subject Matter Expert (SME).

• Review, collect, and integrate TF/DD documents into Adobe PDF format.

• Create and upload bookmarks and indexes of Adobe PDF files into Product Lifecycle Management (PLM) through Change Orders.

• Conduct quality control checks for completeness, pagination, and to ensure there are no blank or missing pages, as well as verifying current document revisions.

• Collaborate with cross-functional teams and local affiliates to gather necessary supporting documents.

• Address inquiries from local affiliates and coordinate responses to health authority-related questions or requests.

• Represent Regulatory Affairs on project teams and communicate regulatory requirements.

• Participate in meetings and engage with the project team.

• Update regulatory management on project status and deliverables.

• Assist with additional regulatory activities as needed.

⛳️ Requirements

• Bachelor’s degree (preferably in life sciences).

• At least 2 years of experience in Regulatory Affairs with a focus on EU MDR.

• Mandatory knowledge of EU MDR, ISO13485, and FDA Medical Device regulations.

• Proficient in Microsoft Office Suite (e.g., Word, Excel, PowerPoint).

• Ability to work effectively in team settings and on diverse projects with minimal supervision.

• Excellent organizational skills, attention to detail, planning capabilities, and communication proficiency.

• Strong written and verbal communication skills in English.

🏝️ Benefits

• Opportunities for professional development.

• A supportive company culture.

• Continuous training programs.

• Commitment to diversity and inclusivity.

• Equal opportunity employment.